Actively Recruiting
A Multicenter, Open-label, Non-randomized Phase I/IIa Clinical Trial to Evaluate INR102 Injection in Patients With Prostate Cancer
Led by Yunhe Pharmaceutical (Tianjin) Co., Ltd · Updated on 2026-01-07
55
Participants Needed
2
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase I/IIa clinical trial to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of INR102 injection in patients with prostate cancer.
CONDITIONS
Official Title
A Multicenter, Open-label, Non-randomized Phase I/IIa Clinical Trial to Evaluate INR102 Injection in Patients With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingly participate and provide informed consent in person
- Be 18 years of age or older at consent
- Histologically or cytologically confirmed prostate cancer excluding neuroendocrine or small cell features
- Positive 18F-PSMA-137 PET/CT scan result
- Maintain castrate-level serum testosterone (<50 ng/dL or <1.7 nmol/L) with confirmed disease progression
- Progression after treatment with at least one novel androgen receptor pathway inhibitor and taxane-based therapies
- Have one or more metastatic lesions confirmed by imaging within 4 weeks prior to administration
- Adequate bone marrow, liver, and kidney function as specified
- ECOG performance status score of 0 to 2
- Expected survival greater than six months
- Use condoms during sex and avoid sperm donation during and for 18 weeks after treatment
You will not qualify if you...
- Received systemic or local radioisotope therapy within 6 months prior to study treatment
- Prior treatment targeting PSMA
- Received systemic anti-tumor treatments or external beam radiotherapy (except palliative) within 28 days before study treatment
- Received traditional Chinese medicine with anti-tumor effects within 2 weeks before study treatment
- Experienced Grade 4 myelosuppression or prolonged Grade 3 myelosuppression after prior therapy
- Blood transfusion within 28 days prior to study treatment
- Ongoing toxicity from prior anti-tumor treatment greater than CTCAE grade 1, except alopecia or peripheral neuropathy recovered to grade 2
- Participated in other interventional clinical trials within 28 days or within five half-lives of investigational drugs
- History of hypersensitivity to 18F-PSMA-137, 177Lu-PSMA-137, their excipients, or similar agents
- Untreated active brain or meningeal metastases
- Claustrophobia or inability to tolerate imaging procedures
- Poor venous access for frequent blood sampling (for PK study participants)
- Severe or uncontrolled medical conditions such as NYHA Class 3 or 4 heart failure, long QT syndrome, active hepatitis B or C, severe infections requiring IV antibiotics
- Other malignant tumors affecting life expectancy or disease evaluation, except those disease-free and treatment-free for over 3 years or certain treated skin and bladder cancers
- Uncontrollable bladder outlet obstruction or urinary incontinence
- Any physical or mental condition that may compromise safety or adherence to study treatment as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China, 214000
Not Yet Recruiting
2
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
D
Dong Yuan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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